Telerehabilitation Following Ankle Fractures

Not Applicable

Completed

• Conditions: Ankle Fractures
• Interventions: Other: Standard rehabilitation; Other: Telerehabilitation

• Registration Number: NCT04235907
• Lead Sponsor: Johns Hopkins University

Brief Summary

Background and Purpose: Ankle fractures represent one of the most common fractures in North America. Surgical fixation is often required in the presence of dislocation or instability and has been shown to have a high rate of success. Following surgical fixation, physical therapy is commonly utilized to assist in regaining function. Advice alone has been shown to be non-inferior to traditional physical therapy for patients post-ankle fracture in two studies. The results of these studies have yet to be repeated in the US. It is the intent of this study to investigate the feasibility of a large clinical trial comparing the results of traditional physical therapy and an internet-based telerehabilitation program. Following surgical repair of ankle fractures, patients will be randomized to traditional rehabilitation or telerehabilitation. Telerehabilitation may represent an alternative patient option to traditional physical therapy following ankle fracture repair. The results of this study will inform the design of larger multi-site clinical trials investigating the effectiveness of telerehabilitation for this patient population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Study Start: 2020-09-28
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Bimalleolar or trimalleolar fracture
• Repaired with open reduction internal fixation technique
• Must have access to computer, tablet, or smart phone with internet access

Exclusion Criteria

• Severe soft tissue damage associated with injury
• Physical or mental conditions that will affect patient's ability to participate in independent rehabilitation
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Physical Therapy	Standard rehabilitation	Patients will be given a prescription to see a physical therapist and a paper-based rehabilitation protocol. Patients will be allowed to receive physical therapy at a location of patients' choosing. This arm represents the current standard of care.
Telerehabilitation	Telerehabilitation	Patients will be given access to a website containing instructions with pictures and videos for the exercises patients are to complete as part of patients' rehabilitation. Patients will not be given a prescription to physical therapy. Patients in this group will receive weekly calls from a physical therapist during weeks 6-12 post-operatively.

Primary Outcome Measures

Name	Time	Method
Change in self-reported function	At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months	Measured by the Lower Extremity Functional Scale, a patient-reported function of the lower extremity. Scores range from 0-80 with lower scores indicating increased impairment levels.

Secondary Outcome Measures

Name	Time	Method
Out of pocket cost	6 months	Patient reported estimate of patients' out of pocket costs associated with rehabilitation.
Self-Efficacy for Home Exercise Program as assessed by a 12-Item questionnaire	2 weeks	12-Item questionnaire assessing self-efficacy for completing assigned home exercises. Scored 0-72 with higher scores indicating increased self-efficacy.
Travel time (hours)	6 months	Patient reported estimate of time spent traveling to and from rehabilitation appointments.
Change in self-reported quality of life	At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months	Measured using the Veterans RAND 12-Item Health Survey. This is a 12-Item global health questionnaire with a physical and mental component scores. Utilizes a t-score method standardized to the US population. Positive t-scores indicate better than average quality of life and negative t-score values represent lower than average quality of life.
Change in pain as assessed by the Brief Pain Inventory short form	At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months	Measured using the Brief Pain Inventory short form. This is a 15-item questionnaire resulting in scores for pain severity and pain interference. Each of these is scored 0-10 with higher scores indicating increased pain severity/interference.
Patient Satisfaction as assessed by a 0-10 satisfaction scale	6 months	Patient reported measure of satisfaction with treatment received and progress made while recovering from injury. Will be measured on a scale of 0-10, with higher scores indicating increased satisfaction with treatment.
Fear of pain with movement as assessed by the Tampa Kinesiophobia Scale	2 weeks	17-Item patient questionnaire assessing fear of movement. Scores range from 17-68 with higher scores indicating increased fear of pain with movement.

Trial Locations

Locations (2)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States